Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03014570 |
| Other study ID # |
HP-00069354 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2016 |
| Est. completion date |
June 1, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This pragmatic trial focuses on implementation of an evidence based process to increase
person-centered management of behavioral and psychological symptoms of dementia (BPSD) in
nursing homes, referred to as EIT-4-BPSD. The findings from this study will add to what is
known about implementation of effective interventions in nursing homes, will serve as a model
for other programs and care approaches, and will help facilities and staff implement quality
person-centered care, which is the goal of the National Partnership to Improve Dementia Care
and Reduce Antipsychotic Use in Nursing Homes.
Description:
Behavioral and Psychological Symptoms of Dementia (BPSD) include aggression, agitation,
depression, anxiety, apathy and hallucinations and are exhibited by up to 90% of nursing
facility residents with dementia. BPSD result in negative health outcomes decline in physical
functioning and high cost of care. In addition, BPSD put residents at risk for inappropriate
use of antipsychotic drugs and other restraining methods that reduce function, increase
social isolation, and increase risk of physical abuse. Prior NIH-funded clinical trials show
that behavioral approaches reduce BPSD. These behavioral approaches are endorsed as the first
line of treatment for BPSD. In fact, the Centers for Medicare and Medicaid Services (CMS)
National Partnership to Improve Dementia Care and Reduce Antipsychotic Use in Nursing Homes
requires that care for residents with dementia be delivered using person-centered behavioral
approaches. Despite regulatory requirements, less than 2% of nursing homes (also referred to
as facilities) consistently implement these approaches. Established barriers to use of
behavioral approaches include limited knowledge, skills, and experience with
non-pharmacological approaches, beliefs in the superiority of psychotropic medications over
behavioral interventions, and lack of staff motivation to use non-pharmacologic strategies
consistently. The proposed project responds to this gap between knowledge and practice. A
novel implementation approach will be tested to assure that staff in nursing homes [i.e.,
those who provide direct care to residents] use non-pharmacologic, behavioral approaches for
the management of BPSD.
To advance the CMS National Partnership, a comprehensive compendium of
peer-reviewed/expert-endorsed resources was developed for utilizing person-centered,
behavioral approaches for BPSD (the Nursing Home Toolkit: www.nursinghometoolkit.com). The
Toolkit has resources that support a theoretically-based 4-step approach that we found
effective in prior implementation work. The four steps include: 1. Assessment of the
environment and policies; 2. Education of staff; 3. Establishing person-centered care plans;
and 4. Mentoring and motivating staff. While the Toolkit is free and accessible, staff in
nursing homes need help with implementation. Implementation of the theoretically based 4-step
approach is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings
together evidence and key stakeholders from the facility to influence care practices. EIT
includes: participatory implementation processes, provision of practical evidence-based
interventions, and pragmatic measures of progress toward goals. This implementation framework
was merged with the 4-step approach and the Nursing Home Toolkit resources to develop the
intervention, EIT-4-BPSD. The goal is to demonstrate that EIT-4-BPSD is an implementation
strategy that enables staff in nursing homes to reduce BPSD using behavioral approaches while
optimizing function, preventing adverse events and improving quality of life of residents. A
Hybrid III cluster randomized trial will be done with 50 nursing facilities randomized to
EIT-4-BPSD or Education Only (EO). The aims are:
Primary Aim 1: To implement and test the implementation of EIT-4-BPSD. Facility Level
Outcome: Research question: Do facilities exposed to EIT-4-BPSD demonstrate evidence of
implementation at 12 months evaluated by the Reach, Effectiveness, Adoption, Implementation,
and Maintenance (RE-AIM) criteria? For evaluation of Effectiveness within RE-AIM: Resident
Level Outcomes: Hypothesis: Residents in EIT-4-BPSD facilities will experience less BPSD,
maintain or improve function, have reduced use of psychotropic medications, experience fewer
adverse events, and have improved quality of life compared to residents in EO facilities. We
will measure these outcomes at baseline, 4 and 12 months post implementation of the
intervention. Facility Level Outcomes: Hypotheses: (1) EIT-4-BPSD facilities will demonstrate
improvements in Environment and Policy assessments that reflect support for behavioral
approaches for BPSD, and will have a greater percentage of residents with behavioral
approaches incorporated into their care plans at 12 months post-implementation when compared
to EO facilities; (2) We will examine Maintenance of EIT-4-BPSD facility outcomes at 12
months and then at 24 months post-implementation.
Primary Aim 2: Evaluation of the Feasibility, Utility and Cost of EIT Approach in EIT-4-BPSD
Facilities. Using descriptive and qualitative data captured during the intervention and from
focus groups at 12 months,use of the EIT strategy and the participatory implementation
process with the Stakeholder Team and facility staff will be evaluated. In addition a
description of the costs of implementation using an activity-based costing method will be
completed.
This study will add critical knowledge to what little is known about implementation of
effective interventions in nursing facilities. It will serve as an implementation model with
potential to be widely disseminated. In addition, the study will demonstrate how facilities
can implement person-centered dementia care and decrease BPSD, the ultimate goal of the CMS
National Partnership.
